Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company, has shared encouraging results from several preclinical studies on its precision antisense drug candidate HT-KIT. The findings show strong anti-tumor effects, a good safety record, and bioanalytical results that meet strict regulatory standards. These results support moving forward with developing HT-KIT for treating cancers caused by the KIT oncogene.
In the preclinical studies, HT-KIT showed quick tumor cell death in models of gastrointestinal stromal tumors and systemic mastocytosis. Tumors started shrinking as early as eight days after treatment. In lab tests, HT-KIT reduced the KIT gene expression by more than 80 percent. Safety tests found no harmful effects on important organs like the liver, kidneys, spleen, bone marrow, or thymus, even with repeated doses. There was also a dose-related effect in the liver, with no visible tissue damage.
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The bioanalytical analysis, done by Altasciences following OECD, FDA, and EMA guidelines, confirmed that HT-KIT met or went beyond all required standards. The evaluation included calibration accuracy, quality controls, and consistent results. Over 90 percent of the retested samples were within acceptable limits, well above what is expected. The drug also showed good stability in serum, staying effective for 37 days at very low temperatures, which is better than the standard 28-day benchmark. There were no deviations from the planned procedures, ensuring the reliability of the data.
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Robb Knie, CEO of Hoth Therapeutics, said, “Combining fast and effective tumor cell destruction, a safe profile across all tested systems, and high-quality, GLP-validated data is very encouraging. We believe HT-KIT has the potential to greatly improve outcomes for patients with KIT-driven cancers. These achievements bring us closer to submitting an Investigational New Drug application and starting human clinical trials.”
Looking ahead, Hoth plans to include this bioanalytical data into their official GLP toxicology package as they prepare for clinical testing. The company is progressing steadily toward the next stage in developing HT-KIT.
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